Compliance Lead

Overview

The Compliance Lead, part of Country Quality Operations within MCCQ in Toronto, Ontario, is responsible for overseeing Country Quality compliance programs, self‑inspections, risk management, and establishment license management (DEL and MDEL) in alignment with Canadian GMP regulations and corporate requirements.

• Develop, implement, and maintain an effective compliance program.
• Ensure site compliance with all laws, regulations, and standards applicable to API importation and finished goods importation and distribution.
• Establish and maintain relationships with regulators, industry associations, customers, suppliers, and stakeholders; represent the company in compliance matters.
• Maintain systems to identify, track, and mitigate compliance, regulatory, and quality risks.
• Prepare for inspections by regulatory bodies and ensure timely reporting of compliance or drug shortage issues.
• Manage and resolve compliance issues or allegations, applying corrective and preventive actions.
• Set KPIs and metrics for site compliance and report results to management.
• Drive risk management, self‑inspection, and quality alert management.
• Identify and implement continuous improvement initiatives to enhance compliance.
• Define regulatory and license impact of changes to site products and services.
• Ensure compliance of imported products and medical devices with applicable registrations, laws, and regulations.
• Lead inspection readiness and manage inspection teams.
• Track, request, compile GMP evidence from contractors to support importation/distribution into Canada.
• Maintain Canadian Drug Establishment License (DEL) and Medical Device Establishment License (MDEL).
• Manage vendor qualifications, audits, and quality agreements; ensure commitments are met.
• Support new product launches, special projects, marketing and business development groups.
• Manage label changes and ensure compliance with Health Canada regulations.
• Oversee quality questions from Medical Information department; participate in cross‑functional teams.
• Provide backup support to the Country Quality Head and other Quality Leads.
• Manage QA staff and external consultants as needed.

• University degree in a science related to pharmaceutical work;
  Canadian or recognized equivalent.
• 10–15 years of experience in the pharmaceutical industry (QA, QC, Production, or equivalent).
• Minimum 7 years of hands‑on experience with imported pharmaceutical products and Health Canada regulations.
• Strong understanding of Canadian GMPs related to importation and distribution.
• Proven experience managing DEL and MDEL establishment licenses.
• Experience managing cross‑functional teams and external consultants.
• Track record in inspection management and regulatory authority interactions.
• Background in risk management and compliance program development.
• Strong management and leadership skills.
• Excellent English language skills;
  French a plus.

• Competitive salary range:  –  CAD (includes target bonus).
• Health and wellbeing benefits including high‑quality healthcare, prevention, and wellness programs.
• Well‑crafted rewards package that recognizes contributions and amplifies impact.

Sanofi is an equal‑opportunity employer committed to diversity and inclusion. We welcome applications from all qualified candidates. Accommodations for persons with disabilities are available upon request.